Cubicin Rf Lyophilized Powder for Injection / Infusion
Daptomycin
500mg
CUBIST PHARMACEUTICALS, LLC;
| Pack size | 1 Glass Vial (10ml) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 2207.00 AED |
Indications
Cubicin Rf Lyophilized Powder for Injection / Infusion is used for:
Complicated skin and skin structure infections, Staphylococcus aureus bacteraemia
Adult Dose
Intravenous
Complicated skin and skin structure infections
Adult: 4 mg/kg once daily for 7-14 days, by infusion over 30 min or by inj over 2 min.
Staphylococcus aureus bacteraemia
Adult: 6 mg/kg once daily for 2-6 wk, by infusion over 30 min.
Child Dose
Staphylococcus Aureus Bacteremia
Indicated for treatment of children aged 1-17 years with Staphylococcus aureus bacteremia
<1 year: Safety and efficacy not established (see Dosing Considerations)
>1 year
12-17 years: 7 mg/kg IV q24hr
7-11 years: 9 mg/kg IV q24hr
1-6 years: 12 mg/kg IV q24hr
Duration of therapy: Up to 42 days
Complicated Skin & Skin Structure Infections
Indicated for the treatment of adult and pediatric patients (aged 1 to 17 yr) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria
<1 year: Safety and efficacy not established (see Dosing Considerations)
>1 year
12-17 years: 5 mg/kg IV q24hr
7-11 years: 7 mg/kg IV q24hr
2-6 years: 9 mg/kg IV q24hr
1 to <2 years: 10 mg/kg IV q24hr
Duration of therapy: Up to 14 days
Renal Dose
Renal impairment
Complicated skin & skin structure infections (cSSSI)
CrCl >30 mL/min: 4 mg/kg IV q24hr
CrCl <30 mL/min: 4 mg/kg IV q48hr
Hemodialysis and CAPD: 4 mg/kg IV q48hr administer following hemodialysis on hemodialysis days
Staphylococcus aureus bacteremia
CrCl >30 mL/min: 6 mg/kg IV q24hr
CrCl <30 mL/min: 6 mg/kg IV q48hr
Hemodialysis and CAPD: 6 mg/kg IV q48hr administer following hemodialysis on hemodialysis days
Administration
Reconstitute w/ 10 mL of NaCl 0.9% inj using aseptic technique. Gently rotate the vial to wet the powd and allow it to stand for 10 min. To obtain a completely reconstituted soln, gently swirl or rotate the vial. Do not shake/agitate vial during and after reconstitution. Further dilute the reconstituted soln w/ NaCl 0.9% inj for IV infusion. The final concentration should not exceed 20 mg/mL.
IV Administration
Adults
On hemodialysis days, administer after hemodialysis
IV push: Administer reconstituted solution IV over 2 min (in adults only)
IV infusion: Infuse diluted solution IV over 30 min
Pediatrics
1-6 years: Infuse diluted IV solution at rate of 0.42 mL/min over a 60-min period
7-17 years: Infuse diluted IV solution at rate of 1.67 mL/min over a 30-min period
Do not administer Cubicin RF by injection over a two (2) minute period to 1-17 years
Contra Indications
Hypersensitivity
Precautions
Renal impairment. Patient w/ persisting or relapsing Staphylococcus aureus infection. Pregnancy and lactation.
Closely monitor for signs and symptoms of eosinophilic pneumonia (e.g. new onset or worsening fever, dyspnoea). Serum creatine kinase should be monitored at least wkly during therapy.
Pregnancy-Lactation
Pregnancy
Limited published data on use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; no evidence of adverse developmental outcomes observed in animal reproduction studies
Lactation
Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of maternal dose; there is no information on effects of daptomycin on breastfed infant or effects of daptomycin on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from the underlying maternal condition
Interactions
Enhanced adverse/toxic effects w/ HMG-CoA reductase inhibitors (e.g. simvastatin). NSAIDs (e.g. diclofenac, ibuprofen) may reduce excretion of daptomycin and increase risk of renal impairment. Synergistic antibacterial effects against staphylococci and enterococci w/ aminoglycosides (e.g. gentamicin, tobramycin), rifampicin or β-lactam anti-infectives (e.g. penicillins, cephalosporins).
Adverse Effects
Side effects of Daptomycin :
1-10%
Insomnia (9.0%)
Pharyngolaryngeal pain (8.0%)
Chest pain (7.0%)
Elevated blood creatine phosphokinase (7.0%)
Edema (7.0%)
Abdominal pain (6.0%)
Hypertension (6.0%)
Pruritus (6.0%)
Headache (5.4%)
Diarrhea (5.2%)
Sweating (5.0%)
Bacteremia (5.0%)
Sepsis (5.0%)
Rash (4.3%)
Abnormal LFTs (3.0%)
UTI (2.4%)
Hypotension (2.4%)
Dizziness (2.2%)
Dyspnea (2.1%)
Mechanism of Action
Daptomycin is a cyclic lipopeptide antibacterial derived from the fermentation of Streptomyces roseosporus. It causes bacterial cell death by binding to bacterial membranes and disrupting the membrane potential; thus inhibiting the synthesis of protein, DNA and RNA. Daptomycin exhibits rapid concentration-dependent bactericidal effects against susceptible gm+ve bacteria in vitro.
Note
Cubicin Rf 500mg Lyophilized Powder for Injection / Infusion manufactured by CUBIST PHARMACEUTICALS, LLC;. Its generic name is Daptomycin. Cubicin Rf is availble in United Arab Emirates.
Farmaco UAE drug index information on Cubicin Rf Lyophilized Powder for Injection / Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.